We are seeking a Regulatory Affairs Specialist to ensure our products comply with all applicable regulations and standards. You will be responsible for preparing and submitting regulatory filings, monitoring regulatory changes, and providing guidance to internal teams on regulatory requirements. Your expertise will be crucial in ensuring our products can be safely and legally marketed.
Key Responsibilities:
* Prepare and submit regulatory filings to relevant agencies.
* Monitor and interpret regulatory changes.
* Provide guidance to internal teams on regulatory requirements.
* Maintain regulatory documentation and databases.
* Participate in regulatory audits and inspections.
Required Skills:
* Knowledge of regulatory requirements for medical devices.
* Strong attention to detail and accuracy.
* Excellent communication and writing skills.
* Ability to work independently and as part of a team.
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